Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018343
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPOTEN CAPTOPRIL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CAPOTEN CAPTOPRIL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CAPOTEN CAPTOPRIL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CAPOTEN CAPTOPRIL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CAPOTEN CAPTOPRIL 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CAPOTEN CAPTOPRIL 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CAPOTEN CAPTOPRIL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/06/1981 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/01/2017 SUPPL-87 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018343s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018343Orig1s087ltr.pdf
06/19/2015 SUPPL-86 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018343Orig1s086ltr.pdf
12/24/2014 SUPPL-85 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018343s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018343Orig1s085ltr.pdf
08/27/2012 SUPPL-84 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018343s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018343Orig1s084ltr.pdf
12/14/2011 SUPPL-83 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018343s083ltr.pdf
05/19/2011 SUPPL-82 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018343s082ltr.pdf
09/25/2008 SUPPL-81 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018343s081ltr.pdf
05/07/2004 SUPPL-75 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18343slr075ltr.pdf
04/20/1999 SUPPL-73 Labeling

Label is not available on this site.

01/09/1998 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1997 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1996 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

03/01/1996 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1996 SUPPL-68 Labeling

Label is not available on this site.

03/06/1995 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1995 SUPPL-66 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/04/1993 SUPPL-65 Labeling

Label is not available on this site.

01/28/1994 SUPPL-64 Efficacy-New Indication

Label is not available on this site.

03/31/1994 SUPPL-63 Labeling

Label is not available on this site.

05/12/1993 SUPPL-62 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/25/1992 SUPPL-61 Labeling

Label is not available on this site.

09/03/1992 SUPPL-60 Labeling

Label is not available on this site.

12/21/1992 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1992 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/1995 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1992 SUPPL-56 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/07/1991 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

01/31/1991 SUPPL-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/12/1991 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

11/05/1990 SUPPL-52 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/21/1991 SUPPL-51 Labeling

Label is not available on this site.

09/27/1990 SUPPL-50 Labeling

Label is not available on this site.

05/10/1990 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

09/23/1993 SUPPL-48 Efficacy-New Indication

Label is not available on this site.

05/03/1989 SUPPL-47 Labeling

Label is not available on this site.

10/19/1989 SUPPL-46 Labeling

Label is not available on this site.

05/13/1988 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1988 SUPPL-44 Labeling

Label is not available on this site.

06/26/1987 SUPPL-41 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/13/1988 SUPPL-40 Efficacy-New Indication

Label is not available on this site.

01/06/1987 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/21/1987 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1987 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1987 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/14/1986 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/24/1986 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1990 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1986 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1986 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1986 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1986 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/17/1986 SUPPL-27 Labeling

Label is not available on this site.

12/18/1985 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/16/1985 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1985 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/16/1985 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1984 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1984 SUPPL-21 Labeling

Label is not available on this site.

07/12/1984 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/17/1985 SUPPL-18 Efficacy

Label is not available on this site.

09/18/1984 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1984 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/08/1984 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/1984 SUPPL-14 Efficacy

Label is not available on this site.

10/14/1983 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/07/1984 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/14/1983 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/18/1983 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1985 SUPPL-9 Labeling

Label is not available on this site.

02/07/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/09/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1982 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/1982 SUPPL-5 Efficacy

Label is not available on this site.

11/30/1981 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/27/1981 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1981 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/01/2017 SUPPL-87 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018343s087lbl.pdf
06/19/2015 SUPPL-86 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf
12/24/2014 SUPPL-85 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018343s085lbl.pdf
08/27/2012 SUPPL-84 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018343s084lbl.pdf
12/14/2011 SUPPL-83 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s083lbl.pdf
05/19/2011 SUPPL-82 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s082lbl.pdf

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